Ultomiris Европска Унија - Пољски - EMA (European Medicines Agency)

ultomiris

alexion europe sas - ravulizumab - hemoglobinuria, paroksysmal - selektywne leki immunosupresyjne - paroxysmal nocturnal haemoglobinuria (pnh)ultomiris is indicated in the treatment of adult and paediatric patients with a body weight of 10 kg or above with pnh:- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months (see section 5. atypical haemolytic uremic syndrome (ahus)ultomiris is indicated in the treatment of patients with a body weight of 10 kg or above with ahus who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab (see section 5. generalized myasthenia gravis (gmg)ultomiris is indicated as an add-on to standard therapy for the treatment of adult patients with gmg who are anti-acetylcholine receptor (achr) antibody-positive. neuromyelitis optica spectrum disorder (nmosd)ultomiris is indicated in the treatment of adult patients with nmosd who are anti-aquaporin 4 (aqp4) antibody-positive (see section 5. ultomiris is indicated in the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (pnh):- in patients with haemolysis with clinical symptom(s) indicative of high disease activity. - in patients who are clinically stable after having been treated with eculizumab for at least the past 6 months. ultomiris is indicated in the treatment of adult patients with atypical haemolytic uremic syndrome (ahus) who are complement inhibitor treatment-naïve or have received eculizumab for at least 3 months and have evidence of response to eculizumab.

Idefirix Европска Унија - Пољски - EMA (European Medicines Agency)

idefirix

hansa biopharma ab - imlifidase - desensitization, immunologic; kidney transplantation - leki immunosupresyjne - idefirix is indicated for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. the use of idefirix should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.

Clodivac zawiesina do wstrzykiwań Пољска - Пољски - myHealthbox

clodivac zawiesina do wstrzykiwań

ibss biomed s.a. - błonicy, tężcowi tężca - zawiesina do wstrzykiwań - szczepionka tężcowo-błonicza adsorbowana zawiesina do wstrzykiwań (dla dorosłych i młodzieży)

Balsolan 100 mg/g Maść Пољска - Пољски - URPL (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych)

balsolan 100 mg/g maść

grzegorz nowakowski przedsiębiorstwo produkcji farmaceutycznej "gemi" - balsamum peruvianum - maść - 100 mg/g

Enhertu Европска Унија - Пољски - EMA (European Medicines Agency)

enhertu

daiichi sankyo europe gmbh - trastuzumab deruxtecan - nowotwory piersi - Środki przeciwnowotworowe - breast cancerher2-positive breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-positive breast cancer who have received one or more prior anti-her2-based regimens. her2-low breast cancerenhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic her2-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy (see section 4. non-small cell lung cancer (nsclc)enhertu as monotherapy is indicated for the treatment of adult patients with advanced nsclc whose tumours have an activating her2 (erbb2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. gastric cancerenhertu as monotherapy is indicated for the treatment of adult patients with advanced her2-positive gastric or gastroesophageal junction (gej) adenocarcinoma who have received a prior trastuzumab-based regimen.

Hizentra Европска Унија - Пољски - EMA (European Medicines Agency)

hizentra

csl behring gmbh - ludzka normalna immunoglobulina (scig) - syndrom niedoborów immunologicznych - odporne surowicy i immunoglobuliny, - replacement therapy in adults, children and adolescents (0-18 years) in:- primary immunodeficiency syndromes with impaired antibody production (see section 4. - secondary immunodeficiencies (sid) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (psaf)* or serum igg level of.

Fasenra Европска Унија - Пољски - EMA (European Medicines Agency)

fasenra

astrazeneca ab - benralizumab - astma - preparaty do obturacyjne choroby dróg oddechowych, - fasenra jest wskazany jako uzupełnienie terapii u dorosłych pacjentów z ciężką eozynofilowe astmą, z niedostatecznie kontrolowanym, pomimo wysokich dawek wziewnych glikokortykosteroidów plus o przedłużonym działaniu beta-adrainomimetikov.